A trial to determine: a) the effectiveness of fibre supplement, alpha-cyclodextrin, on cholesterol control in overweight and obese participants with pre diabetes b) the effectiveness of ginseng derivative, Compound K, on blood sugar control in overweight and obese participants with pre diabetes
A double blinded, randomised controlled trial to determine a) the efficacy of alpha-cyclodextrin on cholesterol control, and b) the efficacy of Compound K on glycaemic control in overweight and obese participants with pre-diabetes.
The University of Sydney
400 participants
Jul 1, 2015
Interventional
Conditions
Summary
The current trial is designed to determine: a) The efficacy of alpha-cyclodextrin on cholesterol control, and b) The efficacy of hydrolysed ginseng extract (rich in Compound K) on glycaemic control in overweight and obese participants with pre diabetes. The aim of the weight maintenance sub study is to evaluate the effectiveness of three follow up programmes on weight regain six months after completing a weight loss programme.
Eligibility
Inclusion Criteria6
- Aged 18 years or over
- BMI greater than or equal to 25
- Pre-diabetes (based on ADA guidelines, determined by bloods at the screening visit or 6 months prior to Screening):
- a fasting plasma glucose greater than or equal to 5.6 mmol/L AND/OR
- hour post-challenge (oral glucose tolerance test) plasma glucose greater than or equal to 7.8 mmol/L AND/OR
- HbA1c greater than or equal to 5.7%
Exclusion Criteria27
- Type 2 diabetes criteria are based on ADA guidelines. Participants will be excluded from the study if they have:
- a fasting plasma glucose greater than or equal to 7.0 mmol/L AND/OR
- hour post-challenge (oral glucose tolerance test) plasma glucose greater than or equal to 11.1 mmol/L AND/OR
- HbA1c greater than or equal to 6.5%
- Use of lipid lowering medication
- Use of anti-diabetic medications for pre-diabetes
- Type 1 diabetes
- Unstable angina or recent onset of cardiovascular disease (within 1 month of screening)
- Bariatric surgery
- A history of significant liver, kidney or gastrointestinal disease AND/OR
- ALT or AST > 2.5 times upper limit of normal
- serum creatinine > 1.5 times upper limit of normal or
- eGFR < 60ml/min/1.73m^2 or presence of microalbuminuria
- Chronic diarrhoea, bowel motility problems, or other conditions that could affect intestinal fat absorption
- Untreated thyroid disease
- Greater than 10% change in body weight over the past 3 months
- Alcohol or illicit drug abuse
- Pregnant or breastfeeding women, and women who might be planning pregnancy during the duration of the study
- Use of weight loss medications and other drugs that may affect body weight e.g. anti-psychotics, anti-depressants, or corticosteroids
- Taking the following medications which may show reduced absorption of the investigational products: antibiotics, anticoagulants, anticonvulsants, antiarrhythmics, immunosuppressants, or any other drug that is necessary to take with a meal. Short-term and prophylactic antibiotics may be taken during study participation for up to 14 days, but they should be taken at least 2 hours apart from the study drug
- Commencement of a new prescription medication within 3 months of screening or change in dose regimen of a prescription medication within 1 month of screening
- A history or presence of malignancy [completely resected basal or squamous cell carcinoma of the skin if treatment completed > 6 months prior to enrolment and participants in remission for > 5 years prior to screening remain eligible]
- Inability to read and write English
- A history of frequently changed smoking habits, in addition to smoking cessation within 6 months prior to screening. Those who wish to take on the advice of a 'Quit' smoking programme at the time of screening will be eligible to start the trial after 6 months
- Participants may also be excluded, if in the opinion of the study investigators, they have some other condition or disorder that may adversely affect the outcome of the study or the safety of the participant
- Participation in a clinical trial in the last month
- Unable to commit to the appointment schedule or perform the tasks required in the study.
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Interventions
Weight loss intervention (Baseline-Month 6): Participants will be randomised to one of four groups (NB: 1 active ingredient tablet contains 1000 mg alpha-cyclodextrin and 1 active ingredient capsule contains 160 mg hydrolysed ginseng extract (high in Compound K): Alpha-cyclodextrin (alpha-CD) group: Participants in the alpha-CD group will be asked to take 2 placebo capsules prior to each meal, and 2 x 1 gram alpha-CD tablets directly (within 20 minutes) after each meal 3 times per day. Participants will take a total of 12 pills per day (6 tablets and 6 capsules) for 168 +/-7 days (24 weeks) (6 months). Hydrolysed ginseng extract (HGE) group: Participants in the HGE group will be asked to take 2 x 160 mg HGE capsules prior to each meal, and 2 placebo tablets directly (within 20 minutes) after each meal 3 times per day. Participants will take a total of 12 pills per day (6 tablets and 6 capsules) for 168 +/-7 days (24 weeks) (6 months). Combined therapy group: Participants in the combined therapy group will take 2 x 160 mg HGE capsules prior to each meal and 2 x 1 gram alpha-CD tablets directly (within 20 minutes) after each meal 3 times per day. Participants will take a total of 12 pills per day (6 tablets and 6 capsules) for 168 +/-7 days (24 weeks) (6 months). Behavioural Management Programme: Participants in the standard behavioural management programme alone will be required to take 2 placebo capsules prior to each meal, and 2 placebo tablets directly (within 20 minutes) after each meal 3 times per day. Participants will take a total of 12 pills per day (6 tablets and 6 capsules) for 168 +/-7 days (24 weeks) (6 months). All participants will be enrolled in a lifestyle programme during the initial 6 month intervention period. The intervention will be delivered by an Accredited Practising Dietitian in a one on one, face to face consult, of approximately 30 minutes duration. All participants will attend a 30 minute dietary consult each month for six months. The weight loss diet (total fat intake of < 30% and saturated fat < 10% of total energy) will be hypo-caloric with a 500 kilocalorie deficit per day (based on the Harris Benedict Equation for estimating energy requirements). During the intervention period, medication compliance will be monitored by drug tablet return. Follow up weight maintenance period (Month 6-Month 12): At the end of Month 6, participants will no longer be required to take the investigational supplements. Participants will be randomised to one of three weight maintenance groups. The weight maintenance phase will last for 6 months: The usual care group (group 1): Encourage participants to continue with the individualised prescribed diet and lifestyle goals implemented during the intervention period (Baseline to month 6) to aid with weight maintenance. Participants will be asked to set a personal range for weight maintenance. If they go over that range they will be advised to use the strategies they learned in the weight loss phase to reduce their weight to keep in that target range. Daily self weighing (group 2): Participants will receive the usual care intervention and will also be asked to weigh themselves daily using their own bathroom scales and record it on a record card. Daily self weighing plus accountability (group 3): Participants will receive the usual care intervention and will also be provided with a set of scales and asked to weigh themselves daily and record it on a record card. The scales send the weights to an online program that the investigators can access to examine participants' progress. If the participant does not weigh themselves for 7 days, or if their weight increases by 2 kg or more in 7 days, participants will be emailed to remind them to weight themselves regularly or to restart the use of the behaviours they learned during the 6-month weight loss consultations. All participants will see an Accredited Practising Dietitian for a 30 minute one on one, face to face consultation every three months.
Locations(2)
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ACTRN12614001302640